Covidien Signia Grey Small Diameter Curved Tip recall
Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
Why was Covidien Signia Grey Small Diameter Curved Tip recalled?
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: N0A0191UY N0D0392UY N0F0406UY N0L0708UY N0B0657UY N0E0133UY N0G0907UY N9K0376UY N0C0349UY N0E0956UY N0J0746UY N9K1093UY N0C0492UY N0E1026UY N0K0248UY N9L0796UY N0C1008UY N0F0202UY N0K0803UY N9M0418UY N0D0283UY N0F0221UY N0L0307UY N9M0651UY UDI: 10884521741881 20884521741888
- Product
- Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
- Recalling firm
- Covidien, LP
- Quantity
- 11391 units WW: 5982 US 5409 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
- Recall date
- April 21, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)